RESUMO
INTRODUCTION: Occlusion after infra-inguinal bypass surgery for peripheral artery disease is a major complication with potentially devastating consequences. In this descriptive analysis, we sought to describe the natural history and explore factors associated with long-term major amputation-free survival following occlusion of a first-time infra-inguinal bypass. METHODS: Using a prospective database from a tertiary care vascular center, we conducted a retrospective cohort study of all patients with peripheral artery disease who underwent a first-time infra-inguinal bypass and subsequently suffered a graft occlusion (1997-2021). The primary outcome was longitudinal rate of major amputation-free survival after bypass occlusion. Cox proportional hazard models were used to generate hazard ratios (HRs) and 95% confidence intervals (CIs) to explore predictors of outcomes. RESULTS: Of the 1318 first-time infra-inguinal bypass surgeries performed over the study period, 255 bypasses occluded and were included in our analysis. Mean age was 66.7 (12.6) years, 40.4% were female, and indication for index bypass was chronic limb threatening ischemia (CLTI) in 89.8% (n = 229). 48.2% (n = 123) of index bypass conduits used great saphenous vein, 29.0% (n = 74) prosthetic graft, and 22.8% (n = 58) an alternative conduit. Median (interquartile range) time to bypass occlusion was 6.8 (2.3-19.0) months, and patients were followed for median of 4.3 (1.7-8.1) years after bypass occlusion. Following occlusion, 38.04% underwent no revascularization, 32.94% graft salvage procedure, 25.1% new bypass, and 3.92% native artery recanalization. Major amputation-free survival following occlusion was 56.9% (50.6%-62.8%) at 1 y, 37.1% (31%-43.3%) at 5 y, and 17.2% (11.9%-23.2%) at 10 y. In multivariable analysis, factors associated with lower amputation-free survival were older age, female sex, advanced cardiorenal comorbidities, CLTI at index procedure, CLTI at time of occlusion, and distal index bypass outflow. Initial treatment after occlusion with both a new surgical bypass (HR 0.44, CI: 0.29-0.67) or a graft salvage procedure (HR 0.56, CI: 0.38-0.82) showed improved amputation-free survival. One-year rate of major amputation or death were 59.8% (50.0%-69.6%) for those who underwent no revascularization, 37.9% (28.7%-49.0%) for graft salvage, and 26.7% (17.6%-39.5%) for new bypass. CONCLUSIONS: Long-term major amputation-free survival is low after occlusion of a first-time infra-inguinal bypass. While several nonmodifiable risk factors were associated with lower amputation-free survival, treatment after graft occlusion with either a new bypass or a graft salvage procedure may improve longitudinal outcomes.
Assuntos
Amputação Cirúrgica , Oclusão de Enxerto Vascular , Doença Arterial Periférica , Humanos , Feminino , Masculino , Idoso , Estudos Retrospectivos , Pessoa de Meia-Idade , Amputação Cirúrgica/estatística & dados numéricos , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/mortalidade , Oclusão de Enxerto Vascular/etiologia , Oclusão de Enxerto Vascular/epidemiologia , Salvamento de Membro/estatística & dados numéricos , Salvamento de Membro/métodos , Enxerto Vascular/métodos , Enxerto Vascular/mortalidade , Enxerto Vascular/estatística & dados numéricos , Enxerto Vascular/efeitos adversos , Fatores de Risco , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/mortalidade , Intervalo Livre de ProgressãoRESUMO
BACKGROUND: This study aimed to analyze the clinical outcomes after revascularization for chronic limb-threatening ischemia (CLTI) in patients aged ≥ 80 years and < 80 years. METHODS: We retrospectively analyzed multicenter data of 789 patients who underwent infrainguinal revascularization for CLTI between 2015 and 2021. The end points were 2-year overall survival (OS), amputation-free survival (AFS), limb salvage (LS), and postoperative complications. RESULTS: A total of 90 patients aged ≥ 80 years and 200 patients aged < 80 years underwent bypass surgery (BSX), and 205 patients aged ≥ 80 years and 294 patients aged < 80 years underwent endovascular therapy (EVT). Before the propensity score matching, multivariate analyses showed that age ≥ 80 years, lower body mass index and serum albumin levels, nonambulatory status, and end-stage renal disease were independent risk factors for 2-year mortality in the BSX and EVT groups. After propensity score matching, the 2-year OS was better in the < 80 years cohort than in the ≥ 80 years cohort in both the BSX and EVT groups (P = 0.018 and P = 0.035, respectively). There was no difference in the 2-year LS rates between the < 80 years and the ≥ 80 years cohorts in both the BSX and EVT groups (P = 0.621 and P = 0.287, respectively). According to the number of risk factors, except for age ≥ 80 years, there was no difference in the 2-year AFS rates between the < 80 years and ≥ 80 years cohorts for the BSX and EVT groups with 0-1 risk factor (P = 0.957 and P = 0.655, respectively). However, the 2-year AFS rate was poor, especially in the ≥ 80 years cohort in the BSX with 2-4 risk factors (P = 0.015). The Clavien-Dindo ≥ IV complication rates tended to be higher in the ≥ 80 years cohort than in the < 80 years cohort only in the BSX with 2-4 risk factors (P = 0.056). CONCLUSIONS: Patients with CLTI aged ≥ 80 years had poorer OS than those aged < 80 years. However, there was no difference in LS between the ≥ 80 years and < 80 years cohorts in both the BSX and EVT groups. Although age ≥ 80 years was associated with poorer OS, patients with 0-1 risk factor may benefit from revascularization, including BSX, because no difference was observed in AFS or Clavien-Dindo ≥ IV complications.
Assuntos
Amputação Cirúrgica , Isquemia Crônica Crítica de Membro , Procedimentos Endovasculares , Salvamento de Membro , Doença Arterial Periférica , Complicações Pós-Operatórias , Humanos , Estudos Retrospectivos , Masculino , Idoso de 80 Anos ou mais , Feminino , Fatores de Risco , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/terapia , Fatores de Tempo , Fatores Etários , Idoso , Medição de Risco , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/mortalidade , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/terapia , Intervalo Livre de Progressão , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidade , Resultado do Tratamento , Isquemia/mortalidade , Isquemia/cirurgia , Isquemia/terapia , Isquemia/fisiopatologiaRESUMO
BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) face a high long-term mortality risk. Identifying novel mortality predictors and risk profiles would enable individual health care plan design and improved survival. We aimed to leverage a random survival forest machine-learning algorithm to identify long-term all-cause mortality predictors in patients with CLTI undergoing peripheral vascular intervention. METHODS AND RESULTS: Patients with CLTI undergoing peripheral vascular intervention from 2017 to 2018 were derived from the Medicare-linked VQI (Vascular Quality Initiative) registry. We constructed a random survival forest to rank 66 preprocedural variables according to their relative importance and mean minimal depth for 3-year all-cause mortality. A random survival forest of 2000 trees was built using a training sample (80% of the cohort). Accuracy was assessed in a testing sample (20%) using continuous ranked probability score, Harrell C-index, and out-of-bag error rate. A total of 10 114 patients were included (mean±SD age, 72.0±11.0 years; 59% men). The 3-year mortality rate was 39.1%, with a median survival of 1.4 years (interquartile range, 0.7-2.0 years). The most predictive variables were chronic kidney disease, age, congestive heart failure, dementia, arrhythmias, requiring assisted care, living at home, and body mass index. A total of 41 variables spanning all domains of the biopsychosocial model were ranked as mortality predictors. The accuracy of the model was excellent (continuous ranked probability score, 0.172; Harrell C-index, 0.70; out-of-bag error rate, 29.7%). CONCLUSIONS: Our random survival forest accurately predicts long-term CLTI mortality, which is driven by demographic, functional, behavioral, and medical comorbidities. Broadening frameworks of risk and refining health care plans to include multidimensional risk factors could improve individualized care for CLTI.
Assuntos
Isquemia Crônica Crítica de Membro , Aprendizado de Máquina , Humanos , Masculino , Feminino , Idoso , Medição de Risco/métodos , Isquemia Crônica Crítica de Membro/mortalidade , Estados Unidos/epidemiologia , Fatores de Risco , Idoso de 80 Anos ou mais , Sistema de Registros , Fatores de Tempo , Pessoa de Meia-Idade , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/diagnóstico , Estudos RetrospectivosRESUMO
OBJECTIVE: Comorbid chronic kidney disease (CKD) is associated with worse outcomes for patients with chronic limb-threatening ischemia (CLTI). However, comparative effectiveness data are limited for lower extremity bypass (LEB) vs peripheral vascular intervention (PVI) in patients with CLTI and CKD. We aimed to evaluate (1) 30-day all-cause mortality and amputation and (2) 5-year all-cause mortality and amputation for LEB vs PVI in patients with comorbid CKD. METHODS: Individuals who underwent LEB and PVI were queried from the Vascular Quality Initiative with Medicare claims-linked outcomes data. Propensity scores were calculated using 13 variables, and a 1:1 matching method was used. The mortality risk at 30 days and 5 years in LEB vs PVI by CKD was assessed using Kaplan-Meier and Cox proportional hazards models, with interaction terms added for CKD. For amputation, cumulative incidence functions and Fine-Gray models were used to account for the competing risk of death, with interaction terms for CKD added. RESULTS: Of 4084 patients (2042 per group), the mean age was 71.0 ± 10.8 years, and 69.0% were male. Irrespective of CKD status, 30-day mortality (hazard ratio [HR]: 0.94, 95% confidence interval [CI]: 0.63-1.42, P = .78) was similar for LEB vs PVI, but LEB was associated with a lower risk of 30-day amputation (sub-HR [sHR]: 0.66, 95% CI: 0.44-0.97, P = .04). CKD status, however, did not modify these results. Similarly, LEB vs PVI was associated with a lower risk of 5-year mortality (HR: 0.79, 95% CI: 0.71-0.88, P < .001) but no difference in 5-year amputation (sHR: 1.03, 95% CI: 0.89-1.20, P = .67). CKD status did not modify these results. CONCLUSIONS: Regardless of CKD status, patients had a lower risk of 5-year all-cause mortality and 30-day amputation with LEB vs PVI. Results may help inform preference-sensitive treatment decisions on LEB vs PVI for patients with CLTI and CKD, who may commonly be deemed too high risk for surgery.
Assuntos
Amputação Cirúrgica , Isquemia Crônica Crítica de Membro , Comorbidade , Salvamento de Membro , Doença Arterial Periférica , Insuficiência Renal Crônica , Humanos , Amputação Cirúrgica/mortalidade , Amputação Cirúrgica/efeitos adversos , Masculino , Feminino , Idoso , Insuficiência Renal Crônica/mortalidade , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/diagnóstico , Fatores de Risco , Fatores de Tempo , Medição de Risco , Estados Unidos/epidemiologia , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/complicações , Doença Arterial Periférica/diagnóstico , Idoso de 80 Anos ou mais , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/complicações , Estudos Retrospectivos , Resultado do Tratamento , Pessoa de Meia-Idade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Extremidade Inferior/irrigação sanguínea , Enxerto Vascular/mortalidade , Enxerto Vascular/efeitos adversos , Bases de Dados Factuais , Medicare , Isquemia/mortalidade , Isquemia/cirurgia , Isquemia/diagnóstico , Procedimentos Cirúrgicos Vasculares/mortalidade , Procedimentos Cirúrgicos Vasculares/efeitos adversosRESUMO
OBJECTIVE: This study aimed to evaluate treatment outcomes after bypass surgery or endovascular therapy (EVT) in average- and high-risk patients with chronic limb-threatening ischemia (CLTI). METHODS: We retrospectively analyzed multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. A high-risk patient was defined as one with estimated 30-day mortality rate ≥5% or 2-year survival rate ≤50%, as determined by the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) calculator. The amputation-free survival (AFS), limb salvage (LS), wound healing, and 30-day mortality were compared separately for the average- and high-risk patients between the bypass and EVT with propensity score matching. RESULTS: We analyzed 239 and 31 propensity score-matched pairs in the average- and high-risk patients with CLTI. In the average-risk patients, the 2-year AFS and LS rates were 78.1% and 94.4% in the bypass group and 63.0% and 87.7% in the EVT group (P < .001 and P = .007), respectively. The 1-year wound healing rates were 88.6% in the bypass group and 76.8% in the EVT group, respectively (P < .001). The 30-day mortality was 0.8% in the bypass surgery and 0.8% in the EVT group (P = .996). In the high-risk patients, there was no differences in the AFS, LS, and wound healing between the groups (P = .591, P = .148, and P = .074). The 30-day mortality was 3.2% in the bypass group and 3.2% in the EVT group (P = .991). CONCLUSIONS: Bypass surgery is superior to EVT with respect to the AFS, LS, and wound healing in the average-risk patients. EVT is a feasible first-line treatment strategy for high-risk patients with CLTI undergoing revascularization, based on the lack of significant differences in the 2-year AFS rate, between the bypass surgery and EVT cohorts.
Assuntos
Amputação Cirúrgica , Isquemia Crônica Crítica de Membro , Procedimentos Endovasculares , Salvamento de Membro , Doença Arterial Periférica , Humanos , Estudos Retrospectivos , Masculino , Feminino , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Idoso , Fatores de Risco , Medição de Risco , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/fisiopatologia , Doença Arterial Periférica/diagnóstico por imagem , Fatores de Tempo , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/mortalidade , Pessoa de Meia-Idade , Cicatrização , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidade , Enxerto Vascular/métodos , Idoso de 80 Anos ou mais , Resultado do Tratamento , Isquemia/cirurgia , Isquemia/mortalidade , Isquemia/fisiopatologiaRESUMO
OBJECTIVE: The role of direct oral anticoagulants (DOACs) in chronic limb-threatening ischemia after revascularization is unknown. Current evidence-based guidelines do not provide clear guidance on the role of anticoagulation or the selection of anticoagulant. Current practice is highly varied and based on provider and patient preference. The purpose of this study was to measure the impact of different anticoagulants on the incidence of major adverse limb events (MALEs) after revascularization for chronic limb-threatening ischemia, major adverse cardiovascular events (MACEs), all-cause mortality, and hospitalization for major bleeding events. METHODS: This was a single-center, observational, retrospective cohort study. Subjects were eligible if they were 18 years or older; underwent endovascular or open revascularization for chronic limb-threatening ischemia, rest pain, or tissue loss; and were subsequently prescribed apixaban, rivaroxaban, or warfarin. The primary end point was the incidence of MALEs, including above-ankle amputation or major index-limb reintervention, within 1 year of index event. Secondary end points included the rate of all-cause mortality, MACEs, and incidence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding. RESULTS: From January 1, 2017, to September 20, 2022, 141 patients met the inclusion and exclusion criteria and were reviewed. The median age was 67 years, with 92 patients prescribed apixaban or rivaroxaban and 49 patients prescribed warfarin. Of these, 42 patients were prescribed triple antithrombotic therapy, 88 dual antithrombotic therapy, and 13 anticoagulant monotherapy. The primary outcome of 1-year MALEs occurred in 36.7% of the warfarin group and 33.7% of the DOAC group (relative risk [RR], 1.09; 95% CI, 0.53-2.25; P = .72). Secondary outcomes of 1-year MACEs (10.2% vs 4.3%; RR, 2.35; 95% CI, 0.60-9.18; P = .18) and 1-year all-cause mortality (26.5% vs 16.3%; RR, 1.63; 95% CI, 0.70-3.78; P = .15) did not differ between the groups. The secondary safety outcome of 1-year ISTH major bleeding occurred in 16.3% of the warfarin group and 4.3% of the DOAC group (RR, 3.76; 95% CI, 1.07-13.19; P = .015). CONCLUSIONS: In patients with chronic limb-threatening ischemia who were revascularized and prescribed anticoagulation with apixaban, rivaroxaban, or warfarin on discharge, no difference in MALEs, MACEs, or all-cause mortality was found. However, 1-year admissions for ISTH major bleeding were significantly higher among patients prescribed warfarin. A randomized trial may confirm these findings.
Assuntos
Amputação Cirúrgica , Anticoagulantes , Hemorragia , Pirazóis , Piridonas , Rivaroxabana , Varfarina , Humanos , Masculino , Feminino , Varfarina/efeitos adversos , Varfarina/administração & dosagem , Idoso , Estudos Retrospectivos , Piridonas/efeitos adversos , Piridonas/administração & dosagem , Piridonas/uso terapêutico , Administração Oral , Anticoagulantes/efeitos adversos , Anticoagulantes/administração & dosagem , Anticoagulantes/uso terapêutico , Hemorragia/induzido quimicamente , Resultado do Tratamento , Pirazóis/efeitos adversos , Pirazóis/uso terapêutico , Pirazóis/administração & dosagem , Rivaroxabana/efeitos adversos , Rivaroxabana/administração & dosagem , Rivaroxabana/uso terapêutico , Pessoa de Meia-Idade , Fatores de Tempo , Fatores de Risco , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/complicações , Idoso de 80 Anos ou mais , Inibidores do Fator Xa/efeitos adversos , Inibidores do Fator Xa/administração & dosagem , Inibidores do Fator Xa/uso terapêutico , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/diagnóstico , Medição de Risco , Salvamento de Membro , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidadeRESUMO
OBJECTIVE: This study aimed to evaluate three survival prediction models: the JAPAN Critical Limb Ischaemia Database (JCLIMB), Surgical Reconstruction Versus Peripheral Intervention in Patients With Critical Limb Ischaemia (SPINACH), and Vascular Quality Initiative (VQI) calculators. METHODS: Multicentre data of patients who underwent infrainguinal revascularisation for chronic limb threatening ischaemia between 2018 and 2021 were analysed retrospectively. The prediction models were validated using a calibration plot analysis with the intercept and slope. The discrimination was evaluated using area under the curve (AUC) analysis. The observed two year overall survival (OS) was evaluated by the Kaplan - Meier method. The two year OS predicted by each model at < 50%, 50 - 70%, and > 70% was defined as high, medium, and low risk, respectively. RESULTS: A total of 491 patients who underwent infra-inguinal revascularisation were analysed. The rates of surgical revascularisation, endovascular therapy, and hybrid therapy were 26.5%, 70.1%, and 5.5%, respectively. The average age was 75.6 years, and the percentages of patients with diabetes mellitus and dialysis dependent end stage renal disease were 66.6% and 44.6%, respectively. The tissue loss rate was 85.7%. The intercept and slope were -0.13 and 1.18 for the JCLIMB, 0.11 and 0.82 for the SPINACH, and -0.15 and 1.10 for the VQI. The AUC for the two year OS of JCLIMB, SPINACH, and VQI were 0.758, 0.756, and 0.740, respectively. The observed two year OS rates of low, medium, and high risk using the JCLIMB calculator were 80.1%, 61.1%, and 28.5%, respectively (p < .001), using the SPINACH calculator were 81.0%, 57.0%, and 38.1%, respectively (p < .001), and using the VQI calculator were 77.8%, 45.8%, and 49.6%, respectively (p < .001). CONCLUSION: The JCLIMB, SPINACH, and VQI survival calculation models were useful, although the OS predicted by the VQI model appeared to be lower than the observed OS.
Assuntos
Isquemia Crônica Crítica de Membro , Procedimentos Endovasculares , Humanos , Idoso , Masculino , Feminino , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Estudos Retrospectivos , Medição de Risco/métodos , Japão/epidemiologia , Idoso de 80 Anos ou mais , Isquemia Crônica Crítica de Membro/cirurgia , Isquemia Crônica Crítica de Membro/mortalidade , Fatores de Risco , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Procedimentos Cirúrgicos Vasculares/mortalidade , Resultado do Tratamento , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Doença Arterial Periférica/complicações , Pessoa de Meia-Idade , Salvamento de Membro , Fatores de Tempo , Valor Preditivo dos Testes , Bases de Dados FactuaisRESUMO
INTRODUCTION: Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease and leads high mortality. Sarcopenia, characterized by the loss of muscle mass or poor muscle quality, is associated with adverse clinical outcomes. This study aimed to investigate the association between sarcopenia and the long-term outcomes in patients with CLTI after endovascular revascularization. METHODS: We retrospectively reviewed the medical records of all patients with CLTI who underwent endovascular revascularization between January 2015, and December 2021. The skeletal muscle area was calculated at the third lumbar vertebra from computed tomography images using the manual trace method and normalized to patient height. Sarcopenia was defined as a third lumbar skeletal muscle index of <40.8 cm2/m2 in males and <34.9 cm2/m2 in females. The Kaplan-Meier and Cox proportional hazards regression analyses were used for survival analysis and to evaluate the association between sarcopenia and mortality. RESULTS: A total of 137 patients (90 men; mean age 71.7 ± 9.6 y) were enrolled for the study, of whom 56 (40.8%) had sarcopenia. The 3-year overall survival rate in patients with CLTI who underwent endovascular revascularization was 71.2%. The sarcopenic group had a significantly worse 3-year overall survival rate than the nonsarcopenic group (55.3% versus 78.6%, P = 0.001). Multivariate Cox proportional hazard regression analyses revealed that sarcopenia (hazard ratio, 2.262; 95% confidence interval, 1.132-4.518; P = 0.021) and dialysis (hazard ratio, 3.021; 95% confidence interval, 1.337-6.823; P = 0.008) were independently associated with increased risk of all-cause mortality, whereas technical success had significantly opposing correlation with mortality. (hazard ratio, 0.400, 95% confidence interval, 0.194-0.826, P = 0.013). CONCLUSIONS: Sarcopenia can be highly prevalent in patients with CLTI who undergo endovascular revascularization, and is independently associated with long-term mortality. These results may help risk stratification to assist in personalized assessment and clinical decision-making.
Assuntos
Isquemia Crônica Crítica de Membro , Procedimentos Endovasculares , Sarcopenia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença Crônica , Isquemia Crônica Crítica de Membro/mortalidade , Procedimentos Endovasculares/efeitos adversos , Isquemia/etiologia , Isquemia/cirurgia , Salvamento de Membro/métodos , Doença Arterial Periférica/complicações , Doença Arterial Periférica/cirurgia , Estudos Retrospectivos , Fatores de Risco , Sarcopenia/complicações , Sarcopenia/epidemiologia , Resultado do TratamentoRESUMO
BACKGROUND: Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation. METHODS: We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure. RESULTS: We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported. CONCLUSIONS: We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).
Assuntos
Amputação Cirúrgica , Derivação Arteriovenosa Cirúrgica , Isquemia Crônica Crítica de Membro , Procedimentos Endovasculares , Idoso , Feminino , Humanos , Masculino , Teorema de Bayes , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/cirurgia , Procedimentos Endovasculares/métodos , Procedimentos Endovasculares/mortalidade , Isquemia/mortalidade , Isquemia/cirurgia , Salvamento de Membro/métodos , Salvamento de Membro/mortalidade , Doença Arterial Periférica/mortalidade , Doença Arterial Periférica/cirurgia , Estudos Prospectivos , Fatores de Risco , Resultado do Tratamento , Amputação Cirúrgica/métodos , Amputação Cirúrgica/mortalidade , Úlcera da Perna/fisiopatologia , Úlcera da Perna/cirurgia , Úlcera da Perna/terapia , Cateterismo , Derivação Arteriovenosa Cirúrgica/métodos , Cicatrização , Adulto , Pessoa de Meia-Idade , Idoso de 80 Anos ou mais , Perna (Membro)/irrigação sanguínea , Perna (Membro)/cirurgia , Artérias/cirurgia , Veias/cirurgiaRESUMO
OBJECTIVE: Although it has been shown that patient socioeconomic status (SES) is associated with the surgical treatments chosen for severe peripheral arterial disease (PAD), the association between SES and outcomes of arterial reconstruction have not been well-studied. The objective of this study was to determine if SES is associated with outcomes following lower extremity arterial reconstruction. METHODS: Patients 40 years and older who had surgical revascularization for severe lower extremity PAD were identified in the Nationwide Readmissions Database, 2010 to 2014. Measures of SES including median household income (MHI) quartiles of patients' residential ZIP codes were extracted. Factors associated with repeat revascularization, subsequent major amputations, hospital mortality, and 30-day all-cause readmission were evaluated using multivariable regression analyses. RESULTS: Of the 131,529 patients identified, the majority (61%) were male, and the average age was 69 years. On unadjusted analyses, subsequent amputations were higher among patients in the lowest MHI quartile compared with patients in the highest MHI quartile (13% vs 10%; overall P < .001). On multivariable analyses, compared with patients in the lowest quartile, those in the highest quartile had lower amputation (adjusted odds ratio [aOR], 0.70; 95% confidence interval (CI), 0.63-0.77; overall P < .001) and readmission (aOR, 0.91; 95% CI, 0.84-0.99; overall P = .028) rates. However, subsequent revascularization (aOR, 1.04; 95% CI, 0.94-1.15) and mortality (aOR, 1.01; 95% CI, 0.79-1.28) rates were not different across the groups. CONCLUSIONS: Lower SES is associated with disproportionally worse outcomes following lower extremity arterial reconstruction for severe PAD. These data suggest that improving outcomes of lower extremity arterial reconstruction may involve addressing socioeconomic disparities.
Assuntos
Amputação Cirúrgica/estatística & dados numéricos , Angioplastia/estatística & dados numéricos , Isquemia Crônica Crítica de Membro/cirurgia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Classe Social , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia/economia , Isquemia Crônica Crítica de Membro/mortalidade , Feminino , Disparidades em Assistência à Saúde/economia , Mortalidade Hospitalar , Humanos , Extremidade Inferior/irrigação sanguínea , Extremidade Inferior/cirurgia , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Resultado do TratamentoRESUMO
OBJECTIVE: Combined suprainguinal and infrainguinal revascularization is sometimes necessary in the treatment of patients with chronic limb-threatening ischemia (CLTI). However, data on outcomes of concomitant revascularization procedures are lacking. We studied the outcomes of patients with CLTI who underwent suprainguinal bypass (SIB) alone, SIB with concomitant infrainguinal bypass (IIB), and SIB with concomitant infrainguinal peripheral endovascular intervention (IIPVI). METHODS: We reviewed all patients in the Vascular Quality Initiative with CLTI who underwent SIB from January 2010 to June 2020. Logistic regression, Kaplan-Meier survival estimates, log-rank tests, and Cox regression were used to analyze outcomes. Outcomes were 30-day mortality, perioperative myocardial infarction, perioperative major amputation, 1-year amputation-free survival, and 5-year survival. RESULTS: Of 8037 patients included, 81.3% (n = 6537) underwent SIB alone, 9.7% (n = 783) underwent SIB+IIB, and 8.9% (n = 717) underwent SIB+IIPVI. The indication for surgery was rest pain in 5040 (62.5%) and tissue loss in 3031 (37.6%). There were no significant differences in 30-day mortality and perioperative myocardial infarction rates. However, there was 2.8-fold increased odds of perioperative major amputation in both SIB+IIPVI (odds ratio [OR], 2.76; 95% confidence interval [CI], 1.30-5.88; P = .008) and SIB+IIB (OR, 2.79; 95% CI, 1.38-5.54; P = .004) among patients with rest pain as compared with SIB alone. Comparing SIB+IIPVI with SIB alone, there were no significant differences in 1-year freedom from amputation and amputation-free survival. SIB+IIPVI was associated with a 27% increased risk of 5-year mortality (hazard ratio [HR], 1.27; 95% CI, 1.03-1.55; P = .035). Compared with SIB alone, SIB+IIB was associated with 97% increased risk of 1-year major amputation among patients with rest pain (HR, 1.97; 95% CI, 1.06-3.69; P = .033), but a 47% decreased risk of 1-year major amputation or death for patients with tissue loss (HR, 0.53; 95% CI, 0.37-0.78; P = .001). SIB+IIPVI, compared with SIB+IIB, was associated with a two-fold increased risk of 1-year major amputation or death (HR, 2.04; 95% CI, 1.04-2.23), P = .003) and a 52% increased risk of 5-year mortality (HR,1.52; 95% CI, 1.04-2.24; P = .032) among patients with tissue loss. CONCLUSIONS: This study shows that SIB with concomitant infrainguinal revascularization in patients with rest pain is associated with an increased risk of amputation, whereas SIB+IIB in patients with tissue loss is associated with decreased risk of amputation or death. SIB+IIB outperformed SIB+IIPVI in patients with tissue loss. SIB with infrainguinal revascularization should be limited in patients with rest pain in line with current guidelines, but SIB+IIB may be preferred in patients with tissue loss.
Assuntos
Isquemia Crônica Crítica de Membro/terapia , Procedimentos Endovasculares , Enxerto Vascular , Idoso , Amputação Cirúrgica , Canadá , Isquemia Crônica Crítica de Membro/diagnóstico por imagem , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/fisiopatologia , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Humanos , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Intervalo Livre de Progressão , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Estados Unidos , Enxerto Vascular/efeitos adversos , Enxerto Vascular/mortalidade , Grau de Desobstrução VascularRESUMO
OBJECTIVE: Our institution's multidisciplinary Prevention of Amputation in Veterans Everywhere (PAVE) program allocates veterans with critical limb threatening ischemia (CLTI) to immediate revascularization, conservative care, primary amputation, or palliative limb care according to previously reported criteria. These four groups align with the approaches outlined by the global guidelines for the management of CLTI. In the present study, we have delineated the natural history of the palliative limb care group of patients and quantified the procedural risks and outcomes. METHODS: Veterans prospectively enrolled into the palliative limb cohort of our PAVE program from January 2005 to January 2020 were analyzed. The primary outcome was mortality. The secondary outcomes included overall and limb-related readmissions, limb loss, and wound healing. The clinical frailty scale (CFS) score was calculated, and the 5-year expected mortality was estimated using the Veterans Affairs Quality Enhancement Research Initiative tool. Regression analysis was performed to establish associations among the following variables: mortality, wound, ischemia, and foot infection (WIfI) score, CFS score, overall admissions, and limb-related admissions. RESULTS: The PAVE program enrolled 1158 limbs during 15 years. Of the 1158 limbs, 157 (13.5%) in 145 patients were allocated to the palliative limb care group. The overall mortality of the group was 88.2% (median interval, 3.5 months; range, 0-91 months). Of the 128 patients who had died, 64 (50%) had died within 3 months of enrollment. The predicted 5-year mortality for the group was 66%. The average CFS score for the group was 6.2, denoting persons moderately to severely frail. Using the CFS score, 106 patients were considered frail and 39 were considered not frail. No differences were found in mortality between the frail and nonfrail patients. However, a statistically significant difference was found in early (<3 months) mortality (56.2% vs 37.5%; P = .032). The 30-day limb-related readmission rate was 4.7%. Eventual major amputation was necessary for 18 limbs (11.5%). Wound healing occurred in 30 patients (20.6%). Regression analysis demonstrated no association between the CFS score and mortality (r = 0.55; P = .159) or between the WIfI score and mortality (r = 0.0165; P = .98). However, a significant association was found between the WIfI score and limb-related admissions (r = 0.97; P < .001). CONCLUSIONS: Frail patients with CLTI had high early mortality and a low risk of limb-related complications. They also had a low incidence of deferred primary amputation or limb-related readmissions. In our cohort, the vast majority of patients had died within a few months of enrollment without requiring an amputation. A comprehensive approach to the treatment of CLTI patients should include a palliative limb care option because a significant proportion of these patients will have limited survival and can potentially avoid unnecessary surgery and major amputation.
Assuntos
Isquemia Crônica Crítica de Membro/terapia , Idoso Fragilizado , Fragilidade/diagnóstico , Salvamento de Membro , Cuidados Paliativos , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Isquemia Crônica Crítica de Membro/diagnóstico , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/fisiopatologia , Feminino , Fragilidade/mortalidade , Fragilidade/fisiopatologia , Estado Funcional , Humanos , Salvamento de Membro/efeitos adversos , Salvamento de Membro/mortalidade , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Recuperação de Função Fisiológica , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Veteranos , CicatrizaçãoAssuntos
Amputação Cirúrgica/tendências , COVID-19 , Isquemia Crônica Crítica de Membro/cirurgia , Alocação de Recursos para a Atenção à Saúde/tendências , Acessibilidade aos Serviços de Saúde/tendências , Tempo para o Tratamento/tendências , Procedimentos Cirúrgicos Vasculares/tendências , Isquemia Crônica Crítica de Membro/mortalidade , Simulação por Computador , Humanos , Modelos Estatísticos , Ontário/epidemiologia , Anos de Vida Ajustados por Qualidade de Vida , Resultado do TratamentoRESUMO
Background Critical limb ischemia (CLI) represents the most severe form of peripheral artery disease and is associated with significant mortality and morbidity. Contemporary data comparing the sex differences in trends, revascularization strategies, and in-hospital outcomes among patients with CLI are scarce. Methods and Results Using the National Inpatient Sample database years 2002 to 2015, we identified hospitalizations for CLI. Temporal trends for hospitalizations for CLI were evaluated. The differences in demographics, revascularization, and in-hospital outcomes between both sexes were compared. Among 2 400 778 CLI hospitalizations, 43.6% were women. Women were older and had a higher prevalence of obesity, hypertension, heart failure, and prior stroke. Women were also less likely to receive any revascularization (34.7% versus 35.4%, P<0.001), but the trends of revascularization have been increasing among both sexes. Revascularization was associated with lower in-hospital mortality among women (adjusted odds ratio [OR], 0.76; 95% CI, 0.71-0.81) and men (adjusted OR, 0.69; 95% CI, 0.65-0.73). On multivariable analysis adjusting for patient- and hospital-related characteristics as well as revascularization, women had a higher incidence of in-hospital mortality, postoperative hemorrhage, need for blood transfusion, postoperative infection, ischemic stroke, and discharge to facilities compared with men. Conclusions In this nationwide contemporary analysis of CLI hospitalizations, women were older and less likely to undergo revascularization. Women had a higher incidence of in-hospital mortality and bleeding complications compared with men. Sex-specific studies and interventions are needed to minimize these gaps among this high-risk population.
Assuntos
Isquemia Crônica Crítica de Membro , Mortalidade Hospitalar , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/terapia , Bases de Dados Factuais , Feminino , Mortalidade Hospitalar/tendências , Humanos , Masculino , Distribuição por Sexo , Resultado do TratamentoAssuntos
Isquemia Crônica Crítica de Membro/complicações , Isquemia Crônica Crítica de Membro/cirurgia , Salvamento de Membro , Paraplegia/complicações , Idoso , Isquemia Crônica Crítica de Membro/mortalidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do TratamentoAssuntos
Aterosclerose/terapia , Isquemia Crônica Crítica de Membro , Medição de Risco/métodos , Enxerto Vascular , Causas de Morte , Isquemia Crônica Crítica de Membro/etiologia , Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/cirurgia , Humanos , Japão/epidemiologia , Expectativa de Vida , Mortalidade , Administração dos Cuidados ao Paciente/métodos , Período Pós-Operatório , Prognóstico , Enxerto Vascular/efeitos adversos , Enxerto Vascular/métodosRESUMO
AIM: The latest Global Vascular Guidelines (GVG) recommend assessing the 2-year mortality risk in patients with chronic limb-threatening ischemia (CLTI) before revascularization. This study aimed to reveal whether the Wound, Ischemia and foot Infection (WIfI) classification, developed originally as a risk assessment tool for limb prognosis, would be useful in predicting the 2-year mortality risk in patients with CLTI in the era of GVG and WIfI. METHODS: We retrospectively analyzed 849 patients with CLTI who were primarily treated with endovascular therapy (EVT) between April 2010 and December 2016. The impact of baseline characteristics, including the WIfI classification on mortality risk, was investigated using the Cox proportional hazards regression model. RESULTS: During a mean follow-up of 19.3 months, 243 deaths were observed. The 2-year mortality rate was 32.3%. Multivariate analysis demonstrated that WIfI classification stages (p=0.037), in addition to male sex (p=0.010), age (pï¼0.001), non-ambulatory status (pï¼0.001), body mass index (p=0.002), and hemodialysis (pï¼0.001), were independent predictors for an increased risk of mortality, while the Rutherford classification was not. CONCLUSIONS: WIfI classification stages were independently associated with mortality risk in patients with CLTI undergoing EVT, while the Rutherford classification was not. The WIfI classification would be a practical tool for planning the revascularization strategy in CLTI treatment.
Assuntos
Isquemia Crônica Crítica de Membro/mortalidade , Isquemia Crônica Crítica de Membro/terapia , Procedimentos Endovasculares , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Isquemia Crônica Crítica de Membro/diagnóstico , Feminino , Humanos , Salvamento de Membro , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Diálise Renal , Estudos Retrospectivos , Medição de Risco , Taxa de Sobrevida , Fatores de TempoRESUMO
Abstract Background Arterial diseases represent a severe public health problem in the 21st century. Although men have a higher overall prevalence, reports have suggested that women may exhibit atypical manifestations, be asymptomatic, and have hormonal peculiarities, resulting in worse outcomes and severe emergencies, such as acute limb ischemia (ALI). Objectives To analyze the morbidity and mortality profile of ALI emergencies in Brazil between 2008 and 2019. Methods An ecological study was carried out with secondary data from SIH/SUS, using ICD-10 code I.74 The proportions of emergency hospital admissions and in-hospital mortality rates (HMR) by gender, ethnicity, and age were extracted from the overall figures. P<0.05 was considered significant. Results From 2008 to 2019, there were 195,567 urgent hospitalizations due to ALI in Brazil, 111,145 (56.8%) of which were of men. Women had a higher HMR (112:1,000 hospitalizations) than men (85:1,000 hospitalizations) (p<0.05), and a higher chance of death (OR=1.36; p<0.05). Furthermore, mean survival was significantly higher among men (8,483/year versus 6,254/year; p<0.05). Stratified by ethnicity, women who self-identified as white (OR=1.44; p<0.05), black (OR=1.33; p<0.05), and brown (RR=1.25; p <0.05) had greater chances of death than men in the same ethnicity categories. Moreover, women over the age of 50 years had a higher chance of death, with a progressive increment in risk as age increased. Conclusions There was a trend to worse prognosis in ALI emergencies associated with women, especially in older groups. The literature shows that the reasons for these differences are still poorly investigated and more robust studies of this relevant disease in the area of vascular surgery are encouraged.
Resumo Contexto Doenças arteriais representam um grave problema de saúde pública no século XXI. Apesar de homens apresentarem maior prevalência geral, estudos sugerem que mulheres podem cursar com quadros assintomáticos, clínica atípica e particularidades hormonais, que resultam em desfechos desfavoráveis e urgências graves, como oclusões arteriais aguda (OAA). Objetivos Analisar o perfil de morbimortalidade das urgências em OAA no Brasil entre 2008 e 2019. Métodos Realizou-se estudo ecológico com dados secundários do Sistema de Informações Hospitalares/Sistema Único de Saúde, utilizando-se o código I.74 do Código Internacional de Doenças-10. Dos números absolutos, obteve-se proporções de internamentos de urgência e taxa de mortalidade intra-hospitalar (TMH) por gênero, etnia e idade. Considerou-se p < 0,05 significativo. Resultados Entre 2008 e 2019, houve 195.567 internamentos de urgência por OAA no Brasil, dos quais 111.145 (56,8%) eram homens. Mulheres tiveram maior TMH (112:1.000 hospitalizações) em comparação a homens (85:1.000 hospitalizações) (p < 0,05), assim como maior chance de morte (odds ratio [OR] = 1,36; p < 0,05). Ademais, a média de sobrevida anual foi maior entre homens do que entre mulheres (8.483/ano vs. 6.254/ano, respectivamente; p < 0,05). Estratificando por etnia, mulheres apresentaram maior chance de óbitos entre brancas (OR = 1,44; p < 0,05), pretas (OR = 1,33; p < 0,05) e pardas (razão de risco [RR] = 1,25; p < 0,05), comparadas a homens das mesmas etnias. Nas análises etárias, mulheres com mais de 50 anos apresentaram maior chance de óbito, com aumento progressivo do risco com o envelhecimento. Conclusões Nossas análises comparativas evidenciaram tendência de pior prognóstico nas urgências em OAA associadas a mulheres, sobretudo em grupos de idade avançada. A literatura evidencia que as razões para essas diferenças ainda são pouco estudadas, estimulando investigações mais robustas sobre essa importante casuística da cirurgia vascular.